Table 3.

Adverse events for all participants through 90-day post-LIFU follow-up.

LIFU Dose	Participant	AE	Severity	Relation	Resolved
Lower Dose (60-W)	1	Anxiety	Moderate	Related to disorder	Yes
		Head pain	Mild	Expected procedure finding	Yes
	2	Scalp swelling	Mild	Expected procedure finding	Yes
Enhanced Dose (90-W)	3	Headache	Mild	Expected procedure finding	Yes
		Nausea	Mild	Expected procedure finding	Yes
		Headache	Mild	Expected procedure finding	Yes
		Insomnia	Mild	Unrelated to device and procedure	Yes
		Hypersomnia	Mild	Unrelated to device and procedure	Yes
		Increased appetite	Mild	Unrelated to device and procedure	Yes
	4	Head pain	Mild	Expected procedure finding	Yes

AEs, adverse events; LIFU, low-intensity focused ultrasound; SUD, substance use disorder; W, watts.

AEs were tabulated during the procedure and follow-up visits for all participants and relatedness to study treatment was established. AEs were deemed “definitely”, “probably”, “possibly”, or “unrelated” to LIFU treatment/procedure and were included in the analysis.

At the conclusion of the study, participants reported a total of 10 AEs throughout the 90-day follow-up (lower LIFU dose: 3 total AEs; enhanced LIFU dose: 7 total AEs), 9 of which were mild and 1 of which was moderate (anxiety in one participant who received the lower LIFU dose deemed not related to the LIFU procedure but related to SUD). Six AEs were expected procedure findings (Lower LIFU dose: 2 procedure-related AEs; enhanced LIFU dose: 4 procedure-related AEs). The most common expected AE was headache/head pain (67%; 4/6). All treatment/procedure-related AEs resolved within 24 h following LIFU completion. Four AEs were deemed unrelated to the treatment/procedure.